IDH

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

Retrieved on: 
Thursday, April 25, 2024
Glioma, Shanda, MET, WHO, Temozolomide, Safety, Risk, NMPA, National Medical Products Administration, Glioblastoma, Isocitrate dehydrogenase, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Partnership, Trial of the century, Etoposide, OS, History, CNS, IDH, Patient, Neoplasm, Met, APLM, NSCLC, Lung cancer, Pharmaceutical industry

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points: 
  • "The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
  • Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
  • These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
  • This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China

Retrieved on: 
Thursday, April 25, 2024
Oncology, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Glioma, Shanda, MET, Temozolomide, Safety, Radiation, NMPA, Glioblastoma, Isocitrate dehydrogenase, Prognosis, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Lung cancer, Etoposide, OS, History, Risk, CNS, Therapy, IDH, Patient, Neoplasm, NSCLC, Pharmaceutical industry

This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.

Key Points: 
  • This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.
  • In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA.
  • Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1].
  • The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619).

MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344

Retrieved on: 
Thursday, April 11, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Agreement, Patient, Cancer, Mutation, CDK9, Venetoclax, Colorectal cancer, MEI, Bevacizumab, AML, Research, Cohort, Salvage therapy, Disease, Exercise, Therapy, IDH, Incidence, Neoplasm, Toxicity, Acute myeloid leukemia, FLT3, Standard of care, Death, Clinical trial, VEGF, Calendar, Pharmaceutical industry

With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.
  • The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.
  • Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice.
  • The goal of the formulation effort is to increase biological activity, improve patient convenience of administration and increase commercial opportunity.

DEEPX Expands First-Generation AI Chips into Intelligent Security and Video Analytics Markets

Retrieved on: 
Friday, April 19, 2024
The International, EECP, Artificial intelligence of things, AI, PCI Express, Exhibition, City, Software, OEM, Conference, FPS, Transport, Semiconductor, IDH, LAS, Multimedia, COMPUTEX, Saint Andrew's Society, Health, Medical device

LAS VEGAS and SEOUL, South Korea, April 19, 2024 /PRNewswire/ -- DEEPX, an on-device AI semiconductor company, is announcing plans to expand its first-generation AI chip lineup to focus on the intelligent video analytics and security system market — an expansion driven by key business alliances with global physical security companies, physical security device OEM/ODMs, and IDH companies. To this end, the company recently had an exclusive booth at ISC West (The International Security Conference and Exposition), the world's largest security exhibition held from April 9th to 12th in Las Vegas, USA, where it met with more than 400 companies and more than 600 business representatives from leading global security companies.

Key Points: 
  • LAS VEGAS and SEOUL, South Korea, April 19, 2024 /PRNewswire/ -- DEEPX , an on-device AI semiconductor company, is announcing plans to expand its first-generation AI chip lineup to focus on the intelligent video analytics and security system market — an expansion driven by key business alliances with global physical security companies, physical security device OEM/ODMs, and IDH companies.
  • The global AI video analytics market is expected to grow at a CAGR of 33% from $18.11 billion in 2023 to $75.35 billion by 2028.
  • Faced with communication delays, privacy issues, and network costs in systems that previously ran AI on the cloud or central servers, these markets require the realization of intelligent video analysis functions in real time using on-device AI semiconductors.
  • In addition, a reorganization of the physical security industry's global supply chains is creating an opportunity for DEEPX to accelerate the expansion of its on-device AI solutions.

Diakonos Oncology’s Unique Dendritic Cell Vaccine (DOC1021) Improves Survival Compared to Standard of Care in Phase 1 Trial for Glioblastoma

Retrieved on: 
Tuesday, April 9, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SOC, Survival, IDH, Patient, GBM, RNA, Protein, AACR, Pancreatic cancer, Neoplasm, Prognosis, Poster, Vaccine, FDA, Angiosarcoma, Pharmaceutical industry

Twelve of 16 patients with newly diagnosed GBM remain alive with no serious adverse events attributable to DOC1021.

Key Points: 
  • Twelve of 16 patients with newly diagnosed GBM remain alive with no serious adverse events attributable to DOC1021.
  • “These very encouraging results support our confidence in the potential for our dendritic cell vaccines to significantly improve the lives of patients with the most deadly cancers,” said Mike Wicks, Diakonos CEO.
  • Despite their challenging prognosis, these patients saw a statistically significant improvement in expected overall survival of 7.7 months for similar patients.
  • Diakonos’ dendritic cell vaccines are made with a patient’s own immune cells combined with RNA and proteins prepared from a sample of their tumor.

Linkage of Cancer and Lupus in Gliomas Patients

Retrieved on: 
Monday, March 25, 2024
CD86, OS, TME, Gene, Transforming growth factor beta, CD68, Survival, LGG, Ligand, TGFB2, CD276, IDH, STAT1, Inflammation, Central nervous system, Patient, RNA, Tumor microenvironment, Cancer, Messenger, Macrophage, SLE, Expression, TAM, Treatment, Neoplasm, IRF5, Therapy, TGF, IRF1, TGFB, OTCQB, Demethylation, Vaccine

Dr. Vuong Trieu, CEO and Chairman of Oncotelic, stated, ”Our R&D team has discovered crosstalk between the TGF-β and IFN signaling pathways, linking gliomas and Systemic Lupus Erythematosus (SLE).

Key Points: 
  • Dr. Vuong Trieu, CEO and Chairman of Oncotelic, stated, ”Our R&D team has discovered crosstalk between the TGF-β and IFN signaling pathways, linking gliomas and Systemic Lupus Erythematosus (SLE).
  • Understanding the role of IRF5 in both SLE and cancer opens an avenue for targeting IRF5 or its downstream pathways.
  • LGG patients expressing high levels of TGFB2 and IFNGR2 are over-represented in IDH wild-type tumor samples, suggesting that TGFB2 and IFNGR2 mRNA can be therapeutically targeted in these high-risk patients.
  • Therefore, to improve OS in LGG patients, combination therapies must target TGFB2 and IFN-γ activation (via IRF5 inhibition) or immune therapies targeted against CD276/B7-H3

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024
Orbis, Classification, PFS, European Commission, EMA, Traffic barrier, Progression-free survival, Confidence interval, Committee, Enzyme, MAA, Research and development, ASCO, Malignancy, Physician, FDA, PDUFA, Society, Glioma, TGR, Microsoft Access, Safety, INDIGO, Prognosis, Civil service commission, HR, CHMP, SNO, IDH, Patient, Medicine, BIRC, Public, Disease, Diagnosis, Mutation, Development, NDA, Priority review, Pharmaceutical industry

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

FRED’S TEAM SETS HISTORIC $8 MILLION FUNDRAISING RECORD FOR CANCER RESEARCH

Retrieved on: 
Wednesday, January 17, 2024
IDH, Brain, Patient, Glioma, Research, Berlin Marathon, MD, New York City Marathon, Life, Neuro, TCS, MSK, Neuro-Oncology (journal), Cancer, Nursing, Division, Running, Neurology, Pharmaceutical industry

New York, NY, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Fred’s Team, the official running program of Memorial Sloan Kettering Cancer Center (MSK), set a new single-season fundraising record in 2023 by raising $8 million for cancer research at MSK.

Key Points: 
  • New York, NY, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Fred’s Team, the official running program of Memorial Sloan Kettering Cancer Center (MSK), set a new single-season fundraising record in 2023 by raising $8 million for cancer research at MSK.
  • This new milestone is a testament to the Fred’s Team community’s enduring commitment to MSK’s mission of ending cancer for life.
  • Since 1995, Fred’s Team donors and participants have directed more than $112 million to MSK.
  • Fred’s Team participants get to choose the area of cancer research at MSK that they support with their miles.

Epigenetic Therapeutics Global Markets Research 2023-2028 Featuring Major Players - AstraZeneca, Bristol-Myers Squibb, GSK, Ipsen, Seagen, and Incyte - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 2, 2024
Pharmaceutical, Health, Oncology, AstraZeneca, Breast cancer, Ovarian cancer, IDH, Prevalence, Bristol Myers Squibb, HDAC, Cancer, GSK, Epigenomics, COVID-19, Ageing, KMT, Growth, Row, DNMT, Environment, Pharmaceutical industry

The global epigenetic therapeutics market was valued at $6.4 billion in 2022.

Key Points: 
  • The global epigenetic therapeutics market was valued at $6.4 billion in 2022.
  • Technological innovations in epigenetic drug discovery and development are driving increased use of epigenetic therapeutics, which also is pushing market growth.
  • This report is a comprehensive study of the global market for epigenetic therapeutics.
  • This report examines the factors driving growth in the epigenetic drugs market, and it reviews major players, established companies and new entrants.

Ryvu Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, November 29, 2023
Phase, Conference, AACR, WRN, IDH, MTA, Medulloblastoma, Sarcoma, Research, American Society of Hematology, Phases of clinical research, Society, Therapy, MDS, Pharmacokinetics, Lymphoma, Ruxolitinib, ASH, BioNTech, Common, Incentive program, Syndrome, MEK, Exelixis, Patient, AML, PRMT5, Principal investigator, Pharmaceutical industry

Ryvu’s PRMT5 program and synthetic lethality platform were highlighted with preclinical data recently presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

Key Points: 
  • Ryvu’s PRMT5 program and synthetic lethality platform were highlighted with preclinical data recently presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
  • KRAKOW, Poland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today reported financial results for the third quarter of 2023 and provided a corporate update.
  • “The third quarter and the last months of 2023 proved to be an exceptionally productive period for our company,” said Pawel Przewięźlikowski, CEO of Ryvu Therapeutics.
  • Cash Position – On November 24, 2023, Ryvu Therapeutics held $64.5M in cash, cash equivalents, and bonds, compared to $23.2M at the end of 2022.